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Boston Scientific Quality Analyst I in Arden Hills, Minnesota

Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. About the Role: The Quality Analyst I will provide support to the Arden Hills Operations teams in processing and maintaining system level product containment activities as a part of the non-conforming materials quality system sub-process for Arden Hills. This includes the collection, and analysis of complex query data from several systems (SAP, MES, SAP Business Objects) to help guide the engineering team to document system containment that can be effectively implemented and managed. The Quality Analyst I will serve as a Containment Administrator by assisting in the execution and tracking of assigned deliverables for Product Containment activities. In addition, the Quality Analyst I will assist the Quality System stewards and project managers in the execution of projects designed to improve the compliance, efficiency, and effectiveness of the BSC Quality System. Your responsibilities will include: Works with the Arden Hills Operations Team partners to plan the necessary product containment activities, drafts Quality System deliverables to support containment, reports and conducts the system containment activities, which includes collaboration with operations, process flow determination, critical analysis of activities such as BOM allocation, system data analysis and transactional testing, where appropriate. Identifies opportunities to improve the efficiency and effectiveness of the systems and processes being used for product containment/control (process improvement/reengineering projects). Assess new processes and systems as the scope of Arden Hills operations is growing into adjacent medical device therapy types. Evaluates internal control systems used for Product Containment and recommends improvements. Participates in special projects as they arise, including efficiency projects, streamlining of documentation, cross-site projects, and new Containment Administrator Training. Collaborates with BSC Global personnel to drive improvements within SAP, MES and eCAPA. Supports other BSC sites with product control needs as needed. Performs product control verification role for Arden Hills related prior approval regulatory changes. Work with QA and other leaders to identify areas within the quality system in need of improvement and manage Corrective and Preventive Actions, as necessary. Provide data to direct Supervisor and peer management in Arden Hills and other related sites on status of product containment activities including tracking milestones, proposed completion dates, and other relevant metrics. When assigned a system containment to implement, this resource will ensure that the documentation supporting the containment action meet regulatory and corporate quality system standards. Assists in the facilitation of meetings reviewing the system containment needs and developing containment strategies with customers and fellow Containment Admins. Required Qualifications: Minimum of a Bachelors Degree Minimum of less than one year of experience Preferred Qualifications: Medical device or other regulated industry experience Experience working with software systems that support manufacturing activities (e.g., SAP, MES, Global Workflow, Windchill, etc.) Demonstrated initiative to identify and drive improvements Experience with process mapping Knowledge of CFR and ISO requirements Good communication skills with ability to collaborate cross functionally and be adaptable Ability to manage multiple concurrent deadlines and conflicting pr orities Strong communication (oral and written), interpersonal, and problem-solving skills Requisition ID:578459 Among other requirements, Boston Scientific maintains specific prohibited substancetesting requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code * 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination. Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

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